BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP TEST KIT

    MDR report key: 7063039 · Received November 28, 2017

    Report

    Report Number
    1950204-2017-00420
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Report Date
    May 23, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    CL 1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A US CUSTOMER NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK 2 GP TEST KIT (REFERENCE 21342). THE CUSTOMER REPORTED GETTING AN INTERNAL SYSTEM ERROR (NO NUMBER) AND THE MISIDENTIFICATION OF ENTEROCCUS HIRAE AS ENTEROCOCCUS GALLINARUM. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED SETTING UP THE STRAIN FROM BLOOD AGAR PLATES THAT HAD BEEN INCUBATED FOR 24-30 HRS. SALINE PH AND INOCULUM WERE IN THE EXPECTED RANGE. NO OTHER SET UP INFORMATION WAS PROVIDED. A FRESH STRAIN HAD BEEN ORDERED FROM ATCC AND MICROBIOLOGICS, BUT BOTH SOURCES OF THE STRAIN GAVE THE MISIDENTIFICATION. THE CUSTOMER'S STRAIN AND RAW DATA WAS NOT AVAILABLE FOR THE INVESTIGATION. FOUR (4) LAB REPORTS WERE SUBMITTED, ALL SHOWING AN EXCELLENT IDENTIFICATION OF E. GALLINARUM WITH TWO (2) ATYPICAL POSITIVE REACTIONS (LEUA, ALAA) FOR AN IDENTIFICATION OF E. HIRAE ACCORDING TO THE GP KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS, OR AN ATYPICAL STRAIN. HOWEVER, WITHOUT THE STRAIN OR RAW DATA IT IS NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. NOTE: E. HIRAE ATCC 10541 IS NOT A QC STRAIN FOR THE VIITEK 2 GP CARD. VITEK 2 GP TEST KIT LOT #2420248203 MET FINAL QC RELEASE CRITERIA AND PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 GP TEST KIT (REFERENCE (B)(4)). THE CUSTOMER REPORTED GETTING AN INTERNAL SYSTEM ERROR (NO NUMBER) AND THE MISIDENTIFICATION OF ENTEROCCUS HIRAE AS ENTEROCOCCUS GALLINARUM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842976 VITEK® 2 GP TEST KIT VITEK® 2 GP TEST KIT LQL BIOMERIEUX INC. 21342 2420248203 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1